MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM; MDS

Model Number MT22495

Device Problem Issue With Displayed Error Message (2967)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/27/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Patient contacted dexcom on (b)(6) 2015 to report the receiver displayed system check passed screen on (b)(6) 2015.There was no report injury or medical intervention.No additional patient or event information is available.Complaint device was returned for evaluation.A visual exterior inspection was performed on the receiver and it passed.Data was downloaded from the receiver and reviewed, finding screen error alarm on the date of incident, in addition to a firmware error.A global receiver functional test was performed on the receiver finding no failures related to the customers complaint.Based on the finding of firmware error this is being reported.The complaint was confirmed.The root cause could not be determined post investigation.

• Brand Name: DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: MDS
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence drive; san diego CA 92121
• Manufacturer (Section G): DEXCOM, INC.; 6340 sequence drive; san diego CA 92121
• Manufacturer Contact: kipp durbin ; 6340 sequence drive; san diego, CA 92121 ; 8582000200
• MDR Report Key: 5499133
• MDR Text Key: 40287470
• Report Number: 3004753838-2016-01707
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000156
• UDI-Public: (01)00386270000156(241)MT22495(10)5202786(17)NI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MT22495
• Device Catalogue Number: STK-DR-001
• Device Lot Number: 5202786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 100